FEDERAL RULEMAKING

Regulatory Review 

Processes Could Be 

Enhanced

Statement of Michelle Sager, Director, Strategic 

Issues

Testimony before the Subcommittee on the 

Efficiency and Effectiveness of Federal 

Programs and the Federal Workforce, 

Committee on Homeland Security and 

Governmental Affairs, U.S. Senate

For Release on Delivery 

Expected at 2:30 p.m. EDT

Tuesday, March 11, 2014

GAO-14-423T

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-14-423T, a testimony 

before the Subcommittee on the Efficiency 

and Effectiveness of Federal Programs and 

the Federal Workforce, Committee on 

Homeland Security and Governmental Affairs, 

U.S. Senate 

March 11, 2014

FEDERAL RULEMAKING

Regulatory Review Processes Could Be Enhanced

Why GAO Did This Study

Federal regulation is a basic tool of 

government. Agencies issue 

thousands of regulations each year to 

achieve public policy goals such as 

ensuring that workplaces, air travel, 

foods, and drugs are safe; that the 

nation’s air, water and land are not 

polluted; and that the appropriate 

amount of taxes is collected. 

Congresses and Presidents have 

taken a number of actions to refine and 

reform the regulatory process over the 

last several decades. Among the goals 

of such initiatives are enhancing 

oversight of rulemaking by Congress 

and the President, promoting greater 

transparency and participation in the 

process, and reducing regulatory 

burdens on affected parties. 

Over the past two decades Congress 

has often asked GAO to evaluate the 

implementation of procedural and 

analytical requirements that apply to 

the rulemaking process. The 

importance of improving the 

transparency of the rulemaking 

process emerged as a common theme 

throughout GAO’s body of work. Based 

on that body of work, this testimony 

addresses (1) GAO’s findings and 

recommendations regarding federal 

agencies’ retrospective reviews, (2) 

GAO’s findings and OIRA’s progress to 

date on GAO recommendations to 

improve the transparency of the 

regulatory review process, and (3) 

other opportunities for increasing 

congressional oversight and public 

participation in the rulemaking process.

GAO is not making recommendations 

in this testimony.

What GAO Found

In 2007, GAO found that agencies had conducted more retrospective reviews of 

the costs and benefits of existing regulation than was readily apparent, especially 

to the public. Requirements in statutes or executive directives were sometimes 

the impetus for reviews, but agencies more often conducted these retrospective 

reviews based on their own discretionary authorities. Agencies reported that 

discretionary reviews more often generated actions, such as amending 

regulations or changes to guidance. GAO also found that multiple factors, such 

as data limitations and lack of transparency, impeded agencies’ reviews. GAO 

made 7 recommendations in 2007 to improve the effectiveness and transparency 

of retrospective regulatory reviews. Among GAO’s recommendations were: 

minimum standards for documenting and reporting completed review results; 

including public input as a factor in regulatory review decisions; and 

consideration of how agencies will measure the performance of new regulations. 

In 2011 and 2012, the administration issued new directives to agencies on how 

they should plan and conduct analyses of existing regulations that addressed 

each of GAO’s recommendations.

By executive order, the Office of Management and Budget’s (OMB) Office of 

Information and Regulatory Affairs (OIRA) reviews draft proposed and final rules

from executive agencies, other than independent regulatory agencies. Among 

the purposes of these reviews are ensuring that regulations are consistent with 

applicable law and the President’s priorities and that decisions made by one 

agency do not conflict with the policies or actions taken or planned by another. 

Both OIRA and executive agencies are also required to disclose certain 

information about the review process. In 2003 and 2009, GAO found that the 

OIRA regulatory review process often resulted in changes to agencies’ rules, but 

the transparency and documentation of the review process could be improved.

GAO made 12 recommendations to OMB about the review process. For 

example, GAO recommended that OMB provide guidance to agencies regarding 

documentation of the reasons for an agency’s withdrawal of a draft rule from 

OIRA review and the source or impetus of changes made to rules. OMB to date 

has implemented only 1 of those 12 recommendations—to clarify information 

posted about the topic and participants in meetings with outside parties on rules 

under review. GAO believes that its past recommendations still have merit and 

would improve the transparency of the OIRA review process. 

GAO’s recent work continues to highlight progress in facilitating transparency 

and public participation as well as room for improvement. In 2012, GAO found 

that agencies often requested comments when issuing major rules without a 

notice of proposed rulemaking but missed an opportunity to improve those rules 

because they did not always respond to the comments. GAO’s 2013 review of 

international regulatory cooperation also found opportunities to better facilitate 

public participation in these activities. GAO also found that effective international 

regulatory cooperation requires interagency coordination and effective 

collaboration with federal agency officials’ foreign counterparts. Agency officials 

stated that they cooperate with their foreign counterparts (1) because they are 

operating in an increasingly global environment and many products that agencies 

regulate originate overseas and (2) in an effort to gain efficiencies—for example, 

by sharing resources or avoiding duplicative work.

View GAO-14-423T. For more information, 

contact Michelle Sager, 202-512-6806 or

sagerm@gao.gov. 
 

Page 1 GAO-14-423T 

Chairman Tester, Ranking Member Portman, and Members of the 

Subcommittee:

I am pleased to be here today to discuss the federal rulemaking process, 

focusing in particular, at your request, on agencies’ efforts to 

retrospectively review their existing rules1 and the regulatory review 

process coordinated through the Office of Management and Budget’s 

(OMB) Office of Information and Regulatory Affairs (OIRA).

Federal regulation is a basic tool of government. Agencies issue 

thousands of regulations each year to achieve public policy goals such as 

ensuring that workplaces, air travel, food, and drugs are safe; that the 

nation’s air, water, and land are not polluted; and that the appropriate 

amount of taxes is collected. Congresses and Presidents have taken a 

number of actions to refine and reform the regulatory process over the 

past 30 years. Among the goals of such initiatives are enhancing 

oversight of rulemaking by Congress and the President, promoting 

greater transparency and participation in the process, and reducing 

regulatory burdens on affected parties. OIRA is a key player in the 

regulatory process with its responsibility for ensuring that regulations are 

consistent with applicable law, the President’s priorities, and the 

principles set forth in executive orders, among other things.

During the past two decades Congress has often asked GAO to evaluate 

the implementation of procedural and analytical requirements that apply 

to the rulemaking process.2 Drawing on that body of work, my remarks 

today will specifically summarize (1) our findings and recommendations 

regarding federal agencies’ retrospective regulatory reviews, (2) our

 

1

There is no one standard definition for the variety of activities that might be considered 

retrospective regulatory reviews. For purposes of this statement, the term retrospective 

review generally means any assessment of an existing regulation, for purposes of 

determining whether (1) the expected outcomes of the regulation have been achieved; (2) 

the agency should retain, amend, or rescind the regulation; and/or (3) the actual benefits 

and costs of the implemented regulation correspond with estimates prepared at the time 

the regulation was issued.

2

Under the Congressional Review Act, we also provide the Congress with a report on 

each major rule containing our assessment of whether the promulgating federal agency’s 

submissions to us indicate that it has complied with the procedural steps required by 

various acts and Executive Orders governing the regulatory process. A major rule is one 

that, among other things, has resulted in or is likely to result in an annual effect on the 

economy of $100 million or more. 
 

Page 2 GAO-14-423T 

findings and OIRA’s progress to date on our recommendations to improve 

the transparency of the regulatory review process, and (3) other 

opportunities our work has identified for increasing congressional 

oversight and public participation in the rulemaking process.

My testimony today is primarily based on prior reports and testimonies on 

the rulemaking process prepared at the request of Congress.3 We have 

updated some of the references in this statement to reflect more recent 

executive orders and related OMB guidance. We used multiple 

methodologies to develop the findings, conclusions, and 

recommendations for these prior products. A more detailed discussion of 

prior reports’ objectives, scope, and methodology, including our 

assessment of data reliability, is available in the reports cited in the 

related products list at the end of this statement. The work upon which 

this testimony is based was conducted in accordance with generally 

accepted government auditing standards. Those standards require that 

we plan and perform the audit to obtain sufficient, appropriate evidence to 

provide a reasonable basis for our findings and conclusions based on our 

audit objectives. We believe that the evidence obtained provides a 

reasonable basis for our findings and conclusions based on our audit 

objectives. 

In brief, the importance of improving the transparency of the rulemaking 

process emerged as a common theme throughout our prior body of work. 

In 2007, we found that agencies were conducting many more 

retrospective reviews of their existing regulations than was readily 

apparent to non-federal parties, and documentation and reporting on 

results of those reviews was often lacking. In a series of products from 

1996 through 2009 examining implementation of the OIRA regulatory 

review process, we consistently found that OIRA’s reviews of agencies’ 

draft rules often resulted in changes, but the transparency and 

documentation of the review process could be improved. However, OIRA 

only implemented 1 of our 12 most recent recommendations on this OIRA 

regulatory review process. Our recent work has continued to highlight 

both progress made in facilitating transparency, oversight, and public 

participation in regulatory actions as well as room for improvement.

 

3

A selected list of related GAO products is included at the end of this statement. 
 

Page 3 GAO-14-423T 

In 2007, we evaluated retrospective review activities conducted between 

2001 and 2006 by nine agencies covering health, safety, environmental, 

financial, and economic regulations.4 Agencies reported that the main 

purpose of most of their reviews was to examine the effectiveness of the 

implementation of regulations. We found that the agencies had conducted 

more retrospective reviews, and a greater variety of these reviews (such 

as ones examining the efficiency and effectiveness of regulations and 

others identifying opportunities to reduce regulatory burdens) than was 

readily apparent, especially to the public. Reviews mandated by 

requirements in statutes or executive orders and related OMB 

memorandums were sometimes the impetus for reviews, but agencies 

more often exercised their own discretionary authorities to review 

regulations. As a result of these reviews, agencies amended regulations, 

changed guidance and related documents, decided to conduct additional 

studies, and confirmed that existing rules achieved the intended results. 

Agencies noted that discretionary reviews generated additional action 

more often than mandatory reviews, which most often resulted in no 

changes.

We also found that agencies, to varying extents, were developing written 

procedures, processes, and standards to guide how they select which 

rules to review, analyze those rules, and report the results. Multiple 

factors helped or impeded the conduct and usefulness of retrospective 

reviews. Agencies identified time and resources as the most critical 

barriers, but also cited factors such as data limitations and overlapping or 

duplicative review requirements. Nonfederal parties also identified a lack 

of transparency in agency review processes as a barrier and said they 

were rarely aware of the agencies’ reviews. We made seven 

recommendations for executive action in the 2007 report to improve the 

effectiveness and transparency of retrospective regulatory reviews.5

Among the elements that we recommended incorporating in policies, 

procedures, or guidance were: minimum standards for documenting and 

reporting completed review results; inclusion of public input as a factor in 

regulatory review decisions; and consideration of how agencies will 

measure the performance of new regulations.

 

4

GAO, Reexamining Regulations: Opportunities Exist to Improve Effectiveness and 

Transparency of Retrospective Reviews, GAO-07-791 (Washington, D.C.: July 16, 2007).

5

Appendix I lists the relevant recommendations from our prior reports and indicates 

whether or not each recommendation has been implemented.

Executive Orders and 

OMB Guidance 

Addressed Our Prior 

Recommendations to 

Improve Effectiveness 

and Transparency of 

Retrospective 

Reviews
 

Page 4 GAO-14-423T 

OMB took actions that addressed our recommendations which, if 

effectively implemented, will improve the transparency, credibility, and 

effectiveness of agencies’ retrospective review efforts. For example, in 

2011 and 2012, the administration issued new directives to agencies on 

how they should plan and conduct analyses of existing regulations, 

among other subjects, that addressed each of our prior 

recommendations.6 Collectively, they directed executive agencies and 

encouraged independent regulatory agencies to develop and implement 

plans to periodically review existing significant regulations.7 OMB’s 

guidance on the 2011 and 2012 executive orders advised agencies to 

identify in their final plans specific reforms and initiatives that will 

significantly reduce existing regulatory burdens and promote economic 

growth and job creation.

We are currently completing a report at the request of Senators Ron 

Johnson and Mark Warner concerning agencies’ retrospective regulatory 

analyses under the 2011 and 2012 executive orders. The report will 

identify for selected agencies (1) the results and anticipated outcomes of 

completed retrospective analyses included in agencies’ review plans and 

progress reports, (2) strategies, practices, or factors that facilitated or 

limited agencies’ ability to implement retrospective analyses, and (3) the 

extent to which agencies are incorporating retrospective analyses into 

their processes for measuring and achieving agency priority goals.

 

6

These directives included Executive Orders 13563, 13579, and 13610, along with related 

OMB memoranda. The three executive orders were published at 76 Fed. Reg. 3821 (Jan. 

21, 2011), 76 Fed. Reg. 41,587 (July 14, 2011), and 77 Fed. Reg. 28,469 (May 14, 2012).

We also addressed these recommendations to the Chief Counsel for Advocacy within the 

Small Business Administration, to enhance guidance that the Office of Advocacy provides 

to agencies on compliance with retrospective reviews conducted under the Regulatory 

Flexibility Act. (See 5 U.S.C. § 610.) The Office of Advocacy also took actions to 

implement each of our recommendations.

7

Executive Order 12866 defines significant regulatory actions as those that are likely to 

result in a rule that may: (1) have an annual effect on the economy of $100 million or more 

or adversely affect in a material way the economy, a sector of the economy, productivity, 

competition, jobs, the environment, public health or safety, or state, local, or tribal 

governments or communities; (2) create a serious inconsistency or otherwise interfere 

with an action taken or planned by another agency; (3) materially alter the budgetary 

impact of entitlements, grants, user fees, or loan programs or the rights and obligations of 

recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, 

the President’s priorities, or the principles set forth in Executive Order 12866.The order 

further directs executive branch agencies to conduct and submit to OIRA a regulatory 

analysis for economically significant regulations (those rules under the first item in the 

definition above).
 

Page 5 GAO-14-423T 

In a series of products from 1996 through 2009 examining implementation 

of the OIRA regulatory review process, we consistently found that OIRA’s 

reviews of agencies’ draft rules often resulted in changes, but the 

transparency and documentation of the review process could be 

improved. Unfortunately, as I will detail below, to date, OIRA has 

implemented only 1 of our 12 most recent recommendations on this 

process.

A brief explanation of OIRA’s review process provides helpful context for 

understanding why these findings and recommendations remain relevant 

today. Centralized presidential reviews of agency’s regulations have a 

long history and can be traced back to a program established by 

President Nixon in 1971. President Reagan’s Executive Order 12291 in 

1981 expanded the scope of presidential reviews of rulemakings and 

delegated responsibility for this review function to OIRA.8 President 

Clinton’s issuance of Executive Order 12866 in 1993 established the 

current process and requirements regarding reviews of covered agencies’ 

draft proposed and final rules. More recently, in 2011, President Obama 

issued Executive Order 13563, which supplemented and reaffirmed the 

principles, structures, and definitions governing contemporary regulatory 

review established in the 1993 executive order. The basic procedures and 

requirements for the regulatory review process today follow the provisions 

of that 1993 executive order. This practice of centralized regulatory 

reviews is now well established as part of the rulemaking process, 

although it continues to attract some controversy and criticism.

In essence, OIRA is responsible for the coordinated review of agencies’ 

draft proposed and final rules to ensure that regulations are consistent 

with applicable law, the President’s priorities, and the principles set forth 

in executive orders. OIRA is also to ensure that decisions made by one 

agency do not conflict with the policies or actions taken or planned by 

another agency. Executive agencies, except for independent regulatory 

agencies, are required to submit their significant regulatory actions to 

OIRA for review. OIRA is generally required to complete its review within 

 

8

OIRA was created within OMB as part of the Paperwork Reduction Act of 1980. 44 

U.S.C. 3503.

Aspects of the OIRA 

Regulatory Review 

Process Could Be 

More Transparent
 

Page 6 GAO-14-423T 

90 days after an agency formally submits a draft regulation.9 The review 

process can be summarized as follows:

• OIRA reviews agencies’ draft rules at both the proposed and final 

stages of rulemaking. In each phase, the rulemaking agency submits 

a regulatory review package to OIRA (consisting of the rule, any 

supporting materials, and a transmittal form) and OIRA initiates a 

review.

• During the review process, OIRA analyzes the draft rule in light of 

executive order principles and discusses the package with staff and 

officials at the rulemaking agency, as well as with other agencies with 

which interagency coordination will be necessary. In the course of that 

process, the draft rule that is submitted by the agency often changes. 

In some cases, agencies withdraw the draft rule from OIRA during the 

review period and the rule may or may not be subsequently 

resubmitted to OIRA.

• At the end of the review period, OIRA either concludes that the draft 

rule is consistent with the principles of the executive order (which 

occurs in the vast majority of cases) or returns the rule to the agency

“for further consideration.”

10

• If a draft rule that was determined to be consistent with the executive 

order has been modified in the course of the review, the rule is coded 

in the OIRA database as “consistent with change” (regardless of the 

source or extent of the change). If no changes have been made to the 

draft rule during the review, the rule is coded as “consistent without 

change.” OIRA only codes rules as “consistent without change” if they 

are exactly the same at the end of the review period as the original 

submission. Even editorial changes made at the rulemaking agency’s 

initiative can cause a rule to be coded “consistent with change.” 

 

9

The order provides that the review process may be extended (1) once by no more than 

30 calendar days upon the written approval of the Director of OMB and (2) at the request 

of the agency head.

10Information about regulatory actions under OIRA review, and the outcomes of reviews, 

is available through http://www.reginfo.gov.
 

Page 7 GAO-14-423T 

Executive Order 12866 also contains several transparency provisions that 

require both OIRA and agencies to disclose certain information about the 

OIRA review process. For example, the order requires OIRA to disclose 

information about communications between OIRA and persons not 

employed by the executive branch pertinent to rules under OIRA’s review 

and, if OIRA returns a rule to the issuing agency for reconsideration, the 

executive order requires OIRA to provide a written explanation for the 

return. If a rule is withdrawn from OIRA review, however, the order has no 

requirement for OIRA or the regulatory agency to provide a written 

explanation. After the rule has been published in the Federal Register or 

otherwise issued to the public, the regulatory agency publishing the rule is 

required to

• make available to the public the information provided to OIRA in 

accordance with the executive order;

• identify for the public, in a complete, clear, and simple manner, the 

substantive changes between the draft submitted to OIRA and the 

action subsequently announced; and

• identify for the public those changes in the regulatory action that were 

made at the suggestion or recommendation of OIRA.

These transparency requirements and documentation are not simply a 

matter of administrative paperwork. Agencies’ documentation of the OIRA 

review process and its outcomes become part of the regulatory docket for 

each rulemaking.11 The docket publicly documents the support and basis 

for decisions made about the substance of the rule, thus serving as a 

source of information for decision makers, the general public, and for 

purposes of potential judicial review.

Since the issuance of Executive Order 12866, Congress has periodically 

asked us to examine the implementation of the OIRA regulatory review 

process.12 Multiple products we issued from 1996 through 2009 

 

11A docket is a collection or repository of documents related to a rulemaking or other 

action.

12See, in particular, GAO, Federal Rulemaking: Improvements Needed to Monitoring and 

Evaluation of Rules Development as Well as to the Transparency of OMB Regulatory 

Reviews, GAO-09-205 (Washington, D.C.: Apr. 20, 2009); Rulemaking: OMB’s Role in 

Reviews of Agencies’ Draft Rules and the Transparency of Those Reviews, GAO-03-929

(Washington, D.C.: Sept. 22, 2003); and Regulatory Reform: Changes Made to Agencies’ 

Rules Are Not Always Clearly Documented, GAO/GGD-98-31 (Washington, D.C.: Jan. 8, 

1998). 
 

Page 8 GAO-14-423T 

consistently found that the OIRA regulatory review process often resulted 

in changes to agencies’ rules but the transparency and documentation of 

the review process could be improved. For example, in 2003, we 

examined 85 rules from nine health, safety, or environmental agencies 

that had been changed, returned or withdrawn as a result of the OIRA 

review process. We found that the OIRA review process had significantly 

affected 25 of those 85 rules. While almost all returned rules were from 

the Department of Transportation, the rules that were most often 

significantly changed were from the Environmental Protection Agency. 

OIRA’s suggestions appeared to have at least some effect on almost all 

of the 25 rules’ potential costs and benefits or the agencies’ estimates of 

those costs and benefits. The agencies’ docket files did not always 

provide clear and complete documentation of the changes made during 

OIRA’s review or at OIRA’s suggestion, as required by the executive 

order, though a few agencies exhibited exemplary transparency practices.

In 2009, we again found that OIRA’s reviews of agencies’ draft rules often 

resulted in changes. Of our 12 case-study rules subject to OIRA review, 

10 reviews resulted in changes, about half of which included changes to 

the regulatory text. Agencies used various methods to document OIRA’s 

reviews and these methods generally met disclosure requirements. 

However, we found that agencies could improve the transparency of this 

documentation. In particular, agencies did not always clearly attribute 

changes made at the suggestion of OIRA. Additionally, agencies’ 

interpretations were not necessarily consistent regarding what constitutes 

a substantive change that should be documented to comply with the 

executive order transparency requirements. Both of these issues had 

been identified in our earlier work.13

In our 2003 and 2009 reports, we made a total of 12 recommendations to 

OMB about the review process under Executive Order 12866 (see 

appendix I for a list of the recommendations). In 2003 we made 8 

recommendations targeting several aspects of the OIRA review process 

that remained unclear and where improvements could allow the public to 

better understand the effects of OIRA’s review. For example, these 

aspects included addressing a lack of documentation requirements 

regarding (1) staff-level exchanges during the review process, (2) the 

reasons for withdrawal of a rule, or (3) the source or impetus of changes 

 

13See GAO-03-929 and GAO/GGD-98-31. 
 

Page 9 GAO-14-423T 

made to rules. In 2009, based on similar findings, we made 4 additional 

recommendations that OMB provide guidance to agencies to improve 

transparency and documentation of the OIRA review process. OMB 

generally agreed with the 4 recommendations in our 2009 report, but 

disagreed with 7 of the 8 recommendations in our 2003 report.

OIRA to date has implemented only 1 of those 12 recommendations—to 

more clearly indicate in the posted information which regulatory action 

was being discussed and the affiliations of participants when meeting with 

outside parties regarding draft rules under OIRA review. We believe that 

our past recommendations still have merit and, if acted upon, would 

improve the transparency of the OIRA review process. For example, 

regarding our recommendation that the Administrator of OIRA should 

establish procedures whereby either OIRA or the agencies disclose the 

reasons why rules are withdrawn from OIRA review, we note that OIRA’s 

records on the outcomes of regulatory reviews indicate many more 

withdrawals, which currently require no explanation, than returns, which 

do require explanations.

Importantly, other organizations have raised concerns about the 

timeliness of OIRA regulatory reviews. In particular, the Administrative 

Conference of the United States (ACUS) issued a report and adopted a 

statement in December 2013 on improving the timeliness of OIRA’s 

regulatory review process.14 ACUS noted an increase in average review 

times since 2011, including many reviews that extended well past the 

limits established in Executive Order 12866, while also acknowledging 

that OIRA had recently made progress in addressing the backlog. ACUS 

offered a set of principles for improving the timeliness of review and the 

transparency concerning the causes for delays, such as that OIRA 

should, whenever possible, adhere to the timeliness provisions of 

Executive Order 12866 and, if unable to complete the review of an 

agency’s draft rule within a reasonable time—but in no event beyond 180 

days after submission—should inform the public as to the reasons for the 

delay or return the rule to the submitting agency.

 

14See Administrative Conference Statement #18, Improving the Timeliness of OIRA 

Regulatory Review, adopted December 6, 2013. ACUS is an independent agency in the 

executive branch, established as an advisory agency in administrative law and procedure. 

ACUS has broad authority to conduct studies and make recommendations for improving 

the efficiency, adequacy, and fairness of the procedures agencies use in carrying out 

administrative programs. 
 

Page 10 GAO-14-423T 

Our recent work has continued to highlight both progress made in 

facilitating transparency, oversight, and public participation in regulatory 

actions as well as room for improvement. Improvements made in 

transparency of the rulemaking process benefit not only the public but 

also congressional oversight. In 2012, we reviewed a generalizable 

random sample of 1,338 final rules published during calendar years 2003 

through 2010 to provide information on the frequency, reasons for, and 

potential effects of agencies issuing final rules without a notice of 

proposed rulemaking (NPRM). Before issuing a final rule, agencies are 

generally required to publish an NPRM in the Federal Register. Agencies 

must then respond to public comments when issuing final rules. However, 

agencies may use exceptions in certain circumstances to forgo this 

NPRM process to expedite rulemaking. For example, agencies may use 

the good cause exception when they find that notice and comment 

procedures are “impracticable, unnecessary, or contrary to the public 

interest.” We found that agencies frequently cited the good cause 

exception and other statutory exceptions to publish final rules without 

NPRMs. Agencies did not publish an NPRM for about 35 percent of major 

rules and about 44 percent of nonmajor rules published from 2003 

through 2010.15

We found that agencies, though not required, often requested comments 

on major final rules issued without an NPRM, but they did not always 

respond to the comments received.16 For example, we found that 

agencies requested comments on 77 of the 123 major rules issued 

without an NPRM in our sample. The agencies did not issue a follow-up 

rule or respond to comments on 26 of these 77. This is a missed 

opportunity, because we found that, when agencies did respond to public 

comments, they often made changes to improve the rules. Each of these 

26 rules is economically significant and some of these rules have an 

effect of one billion dollars a year or more. To better balance the benefits 

of expedited rulemaking procedures with the benefits of public comments 

that are typically part of regular notice-and-comment rulemakings, and 

improve the quality and transparency of rulemaking records, we 

 

15GAO, Federal Rulemaking: Agencies Could Take Additional Steps to Respond to Public 

Comments, GAO-13-21 (Washington, D.C.: Dec. 20, 2012). 

16Agencies may solicit comments through the Federal Register when publishing a final 

rule without an NPRM, but the public does not have an opportunity to comment before the 

rule’s issuance, nor is the agency obligated to respond to comments it has received.

Additional 

Opportunities Exist to 

Facilitate 

Congressional 

Oversight and Public 

Participation in the 

Rulemaking Process
 

Page 11 GAO-14-423T 

recommended that OMB, in consultation with ACUS, issue guidance to 

encourage agencies to respond to comments on final major rules, for 

which the agency has discretion, that are issued without a prior notice of 

proposed rulemaking. OMB stated that it did not believe it necessary to 

issue guidance on the topic at that time and has not, to date, taken any 

action to implement our recommendation. We continue to believe that the 

recommendation has merit and urge OMB to reconsider its prior position.

In our 2013 review of international regulatory cooperation we again found 

opportunities to better facilitate public participation in regulatory activities. 

In that report, we noted the growing importance of considering regulations 

in an international context.17 Agency officials stated that they cooperate 

with their foreign counterparts (1) because they are operating in an 

increasingly global environment and many products that agencies 

regulate originate overseas and (2) in an effort to gain efficiencies—for 

example, by sharing resources or avoiding duplicative work.

Agencies’ efforts to cooperate on regulatory programs may also facilitate 

trade and support the competitiveness of U.S. business. Agency officials 

we interviewed said that stakeholder involvement is important and 

nonfederal stakeholders are uniquely positioned to identify and call 

attention to unnecessary differences among U.S. regulations and those of 

its trading partners. However, stakeholders we spoke with, such as 

academics, organizations representing businesses, and consumer 

advocacy groups, said it can be challenging for them to provide input into 

agencies’ international regulatory cooperation activities because of the 

required resources and the difficulty of becoming aware of such activities.

In addition to effective collaboration with affected nonfederal 

stakeholders, effective international regulatory cooperation requires 

interagency coordination and effective collaboration with federal agency 

officials’ foreign counterparts. In an environment of constrained resources 

it is even more important for agencies to share knowledge on the effective 

implementation of international regulatory cooperation.

 

17GAO, International Regulatory Cooperation: Agency Efforts Could Benefit from 

Increased Collaboration and Interagency Guidance, GAO-13-588 (Washington, D.C.: Aug. 

1, 2013).
 

Page 12 GAO-14-423T 

We recommended that the Regulatory Working Group, a forum chaired 

by the OIRA Administrator to assist agencies in identifying and analyzing 

important regulatory issues, establish one or more mechanisms to 

facilitate staff level collaboration on international regulatory cooperation 

issues and include independent regulatory agencies. Such a mechanism 

could be addressed as part of forthcoming guidance on Executive Order 

13609. This May 2012 executive order on promoting international 

regulatory cooperation was intended to provide high-level support and 

direction for U.S. agencies’ international regulatory cooperation efforts. 

The executive order directed agencies to consider addressing 

unnecessary differences in existing regulations and describes processes 

to help avoid regulatory divergence in the future. If implemented, our 

recommendation regarding a staff level collaboration mechanism could 

help ensure that U.S. agencies have the necessary tools and guidance to 

effectively implement international regulatory cooperation.18

Chairman Tester, Ranking Member Portman, and Members of the 

Subcommittee, this concludes my prepared statement. Once again, I 

appreciate the opportunity to testify on these important issues. I would be 

pleased to address any questions you or other members of the 

subcommittee might have at this time.

 

18See GAO, Managing for Results: Implementation Approaches Used to Enhance 

Collaboration in Interagency Groups. GAO-14-220 (Washington, D.C.: Feb. 14, 2014); 

Managing for Results: Key Considerations for Implementing Interagency Collaborative 

Mechanisms, GAO-12-1022 (Washington, D.C.: Sep. 27, 2012); and Results-Oriented 

Government: Practices that Can Help Enhance and Sustain Collaboration among Federal 

Agencies, GAO-06-15 (Washington, D.C.: Oct. 21, 2005).
 

Page 13 GAO-14-423T 

If additional information is needed regarding this testimony, please 

contact Michelle Sager, Director, Strategic Issues, at (202) 512-6806 or 

sagerm@gao.gov. 

GAO Contact
Appendix I: Relevant GAO Recommendations 

on Regulatory Processes

Page 14 GAO-14-423T 

Recommendation Agency affected

Recommendation 

implemented

Rulemaking: OMB’s Role in Reviews of Agencies’ Draft Rules and the Transparency of Those Reviews, 

a

GAO-03-929: 

Published: Sep. 22, 2003.

The Director of the Office of Management and Budget should improve the 

implementation of the transparency requirements in the executive order that 

are applicable to rulemaking agencies. Specifically, the Administrator should 

instruct agencies to put information about changes made in a rule after 

submission for OIRA’s review and those made at OIRA’s suggestion or 

recommendation in the agencies’ public rulemaking dockets, and to do so 

within a reasonable period after the rules have been published.

Executive Office of the 

President: Office of 

Management and Budget

The Director of the Office of Management and Budget should improve the 

implementation of the transparency requirements in the executive order that 

are applicable to rulemaking agencies. Specifically, the Administrator should 

define the types of “substantive” changes during the OIRA review process that 

agencies should disclose as including not only changes made to the regulatory 

text but also other, noneditorial changes that could ultimately affect the rules’ 

application (e.g., explanations supporting the choice of one alternative over 

another and solicitations of comments on the estimated benefits and costs of 

regulatory options).

Executive Office of the 

President: Office of 

Management and Budget

The Director of the Office of Management and Budget should improve the 

implementation of the transparency requirements in the executive order that 

are applicable to OIRA. Specifically, the Administrator should establish 

procedures whereby either OIRA or the agencies disclose the reasons why 

rules are withdrawn from OIRA review.

Executive Office of the 

President: Office of 

Management and Budget

The Director of the Office of Management and Budget should improve the 

implementation of the transparency requirements in the executive order that 

are applicable to OIRA. Specifically, OIRA should reexamine its current policy 

that only documents exchanged by OIRA branch chiefs and above need to be 

disclosed because most of the documents that are exchanged while rules are 

under review at OIRA are exchanged between agency staff and OIRA desk 

officers.

Executive Office of the 

President: Office of 

Management and Budget

The Director of the Office of Management and Budget should improve the 

implementation of the transparency requirements in the executive order that 

are applicable to OIRA. Specifically, the Administrator should more clearly 

indicate in the meeting log which regulatory action was being discussed and 

the affiliations of the participants in those meetings.

Executive Office of the 

President: Office of 

Management and Budget 

The Director of the Office of Management and Budget should change OIRA’s 

database to clearly differentiate within the “consistent with change” outcome 

category which rules were substantively changed at OIRA’s suggestion or 

recommendation and which were changed in other ways and for other reasons.

Executive Office of the 

President: Office of 

Management and Budget

The Director of the Office of Management and Budget should define the 

transparency requirements applicable to the agencies and OIRA in section 6 of 

Executive Order 12866 in such a way that they include not only the formal 

review period, but also the informal review period when OIRA says it can have 

its most important impact on agencies’ rules. Doing so would make the trigger 

for the transparency requirements applicable to OIRA’s and the agencies’ 

interaction consistent with the trigger for the transparency requirements 

applicable to OIRA regarding its communications with outside parties.

Executive Office of the 

President: Office of

Management and Budget

Appendix I: Relevant GAO 

Recommendations on Regulatory Processes
Appendix I: Relevant GAO Recommendations 

on Regulatory Processes

Page 15 GAO-14-423T 

Recommendation Agency affected

Recommendation 

implemented

The Director of the Office of Management and Budget should improve the 

implementation of the transparency requirements in the executive order that 

are applicable to rulemaking agencies. Specifically, the Administrator should 

encourage agencies to use “best practice” methods of documentation that 

clearly describe those changes (e.g., like those used by the Food and Drug 

Administration, the Environmental Protection Agency’s Office of Water, or the 

Federal Motor Carriers Safety Administration).

a

Executive Office of the 

President: Office of 

Management and Budget

Reexamining Regulations: Opportunities Exist to Improve Effectiveness and Transparency of Retrospective Reviews, 

GAO-07-791: Published July 16, 2007.

The Director of the Office of Management and Budget, through the 

Administrator of the Office of Information and Regulatory Affairs (OIRA), and 

the Chief Counsel for Advocacy should develop guidance to regulatory 

agencies to consider or incorporate into their policies, procedures, or agency 

guidance documents that govern regulatory review activities consideration, 

during the promulgation of certain new rules, of whether and how they will 

measure the performance of the regulation, including how and when they will 

collect, analyze, and report the data needed to conduct a retrospective review. 

Such rules may include significant rules, regulations that the agencies know 

will be subject to mandatory review requirements, and any other regulations for 

which the agency believes retrospective reviews may be appropriate.

Executive Office of the 

President: Office of 

Management and Budget: Office 

of Information and Regulatory 

Affairs and the Small Business 

Administration: Office of 

Advocacy



The Director of the Office of Management and Budget, through the 

Administrator of the Office of Information and Regulatory Affairs, and the Chief 

Counsel for Advocacy should develop guidance to regulatory agencies to 

consider or incorporate into their policies, procedures, or agency guidance 

documents that govern regulatory review activities prioritization of review 

activities based upon defined selection criteria. These criteria could take into 

account factors such as the impact of the rule; the length of time since its last 

review; whether changes to technology, science, or the market have affected 

the rule; and whether the agency has received substantial feedback regarding 

improvements to the rule, among other factors relevant to the particular 

mission of the agency.

Executive Office of the 

President: Office of 

Management and Budget: Office 

of Information and Regulatory 

Affairs and the Small Business 

Administration: Office of 

Advocacy



The Director of the Office of Management and Budget, through the 

Administrator of the Office of Information and Regulatory Affairs, and the Chief 

Counsel for Advocacy should develop guidance to regulatory agencies to 

consider or incorporate into their policies, procedures, or agency guidance 

documents that govern regulatory review activities specific review factors to be 

applied to the conduct of agencies’ analyses that include, but are not limited to, 

public input to regulatory review decisions.

Executive Office of the 

President: Office of 

Management and Budget: Office 

of Information and Regulatory 

Affairs and the Small Business 

Administration: Office of 

Advocacy



The Director of the Office of Management and Budget, through the 

Administrator of the Office of Information and Regulatory Affairs, and the Chief 

Counsel for Advocacy should develop guidance to regulatory agencies to 

consider or incorporate into their policies, procedures, or agency guidance 

documents that govern regulatory review activities minimum standards for 

documenting and reporting all completed review results. For reviews that 

included analysis, these minimal standards should include making the analysis 

publicly available.

Executive Office of the 

President: Office of 

Management and Budget: Office 

of Information and Regulatory 

Affairs and the Small Business 

Administration: Office of 

Advocacy


Appendix I: Relevant GAO Recommendations 

on Regulatory Processes

Page 16 GAO-14-423T 

Recommendation Agency affected

Recommendation 

implemented

The Director of the Office of Management and Budget, through the 

Administrator of the Office of Information and Regulatory Affairs, and the Chief 

Counsel for Advocacy should develop guidance to regulatory agencies to 

consider or incorporate into their policies, procedures, or agency guidance 

documents that govern regulatory review activities mechanisms to assess their 

current means of communicating review results to the public and identify steps 

that could improve this communication. Such steps could include considering 

whether the agency could make better use of its agency Web site to 

communicate reviews and results, establishing an e-mail listserve that alerts 

interested parties about regulatory reviews and their results, or using other 

Web-based technologies (such as Web forums) to solicit input from 

stakeholders across the country.

a

Executive Office of the 

President: Office of 

Management and Budget: Office 

of Information and Regulatory 

Affairs and the Small Business: 

Office of Advocacy 

The Director of the Office of Management and Budget, through the 

Administrator of the Office of Information and Regulatory Affairs, and the Chief 

Counsel for Advocacy should develop guidance to regulatory agencies to 

consider or incorporate into their policies, procedures, or agency guidance 

documents that govern regulatory review activities steps to promote sustained 

management attention and support to help ensure progress in institutionalizing 

agency regulatory review initiatives.

Executive Office of the 

President: Office of 

Management and Budget: Office 

of Information and Regulatory 

Affairs and the Small Business: 

Office of Advocacy



In light of overlapping and duplicative review factors in statutorily mandated 

reviews and the difficulties identified by agencies in their ability to conduct 

useful reviews with predetermined time frames, the Administrator of OIRA and 

Chief Counsel for Advocacy should work with regulatory agencies to identify 

opportunities for Congress to revise the timing and scope of existing regulatory 

review requirements and/or consolidate existing requirements.

Executive Office of the 

President: Office of 

Management and Budget: Office 

of Information and Regulatory 

Affairs and the Small Business: 

Office of Advocacy



Federal Rulemaking: Improvements Needed to Monitoring and Evaluation of Rules Development as Well as to the 

Transparency of OMB Regulatory Reviews, GAO-09-205: Published: Apr. 20, 2009.

If the current administration retains Executive Order 12866, or establishes 

similar transparency requirements, to improve the monitoring and evaluation of 

rules development and the transparency of the review process, the Director of 

OMB, through the Administrator of OIRA, should define in guidance what types 

of changes made as a result of the OIRA review process are substantive and 

need to be publicly identified to more consistently implement the order’s 

requirement to provide information to the public “in a complete, clear, and 

simple manner.” 

Executive Office of the 

President: Office of 

Management and Budget

If the current administration retains Executive Order 12866, or establishes 

similar transparency requirements, to improve the monitoring and evaluation of 

rules development and the transparency of the review process, the Director of 

OMB, through the Administrator of OIRA, should direct agencies to clearly 

state in final rules whether they made substantive changes as a result of the 

OIRA reviews to more consistently implement the order’s requirement to 

provide information to the public “in a complete, clear, and simple manner.” 

Executive Office of the 

President: Office of 

Management and Budget

If the current administration retains Executive Order 12866, or establishes 

similar transparency requirements, to improve the monitoring and evaluation of 

rules development and the transparency of the review process, the Director of 

OMB, through the Administrator of OIRA, should standardize how agencies 

label documentation of these changes in public rulemaking dockets to more 

consistently implement the order’s requirement to provide information to the 

public “in a complete, clear, and simple manner.” 

Executive Office of the 

President: Office of 

Management and Budget
Appendix I: Relevant GAO Recommendations 

on Regulatory Processes

Page 17 GAO-14-423T 

Recommendation Agency affected

Recommendation 

implemented

If the current administration retains Executive Order 12866, or establishes 

similar transparency requirements, to improve the monitoring and evaluation of 

rules development and the transparency of the review process, the Director of 

OMB, through the Administrator of OIRA, should instruct agencies to clearly 

attribute those changes “made at the suggestion or recommendation of OIRA 

to more consistently implement the order’s requirement to provide information 

to the public “in a complete, clear, and simple manner.” 

a

Executive Office of the 

President: Office of 

Management and Budget

Federal Rulemaking: Agencies Could Take Additional Steps to Respond to Public Comments, GAO-13-21: Published: Dec. 

20, 2012.

To better balance the benefits of expedited rulemaking procedures with the 

benefits of public comments that are typically part of regular notice-andcomment rulemakings, and improve the quality and transparency of rulemaking 

records, the Director of OMB, in consultation with the Chairman of 

Administrative Conference of the United States (ACUS), should issue guidance 

to encourage agencies to respond to comments on final major rules, for which 

the agency has discretion, that are issued without a prior notice of proposed 

rulemaking.

Executive Office of the 

President: Office of 

Management and Budget

International Regulatory Cooperation: Agency Efforts Could Benefit from Increased Collaboration and Interagency 

Guidance, GAO-13-588: Published: Aug. 1, 2013.

To ensure that U.S. agencies have the necessary tools and guidance for 

effectively implementing international regulatory cooperation, the Regulatory 

Working Group, as part of forthcoming guidance on implementing Executive 

Order 13609, should establish one or more mechanisms, such as a forum or 

working group, to facilitate staff level collaboration on international regulatory 

cooperation issues and include independent regulatory agencies.

Executive Office of the 

President: Office of 

Management and Budget: 

Regulatory Working Group

Source: GAO. 

a

Checkmarks indicate that the recommendation has been closed as implemented.
Related GAO Products

Page 18 GAO-14-423T 

International Regulatory Cooperation: Agency Efforts Could Benefit from 

Increased Collaboration and Interagency Guidance. GAO-13-588. 

Washington, D.C.: August 1, 2013.

Federal Rulemaking: Agencies Could Take Additional Steps to Respond 

to Public Comments. GAO-13-21. Washington, D.C.: December 20, 2012.

Federal Rulemaking: Improvements Needed to Monitoring and Evaluation 

of Rules Development as Well as to the Transparency of OMB Regulatory 

Reviews. GAO-09-205. Washington, D.C.: April 20, 2009.

Reexamining Regulations: Opportunities Exist to Improve Effectiveness 

and Transparency of Retrospective Reviews. GAO-07-791. Washington, 

D.C.: July 16, 2007.

Federal Rulemaking: Past Reviews and Emerging Trends Suggest Issues 

That Merit Congressional Attention. GAO-06-228T. Washington, D.C.: 

November 1, 2005.

Rulemaking: OMB’s Role in Reviews of Agencies’ Draft Rules and the 

Transparency of Those Reviews. GAO-03-929. Washington, D.C.: 

September 22, 2003.

Regulatory Reform: Procedural and Analytical Requirements in Federal 

Rulemaking. GAO/T-GGD/OGC-00-157. Washington, D.C.: June 8, 2000.

Regulatory Reform: Changes Made to Agencies’ Rules Are Not Always 

Clearly Documented. GAO/GGD-98-31. Washington, D.C.: January 8, 

1998.

Regulatory Reform: Agencies’ Efforts to Eliminate and Revise Rules Yield 

Mixed Results. GAO/GGD-98-3. Washington, D.C.: October 2, 1997.

Regulatory Reform: Implementation of the Regulatory Review Executive 

Order. GAO/T-GGD-96-185. Washington, D.C.: September 25, 1996.

Related GAO Products

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